Kornimate/medical-research-clean huggingface dataset:
faza pet/mri sarcoma

Conditions: Sarcoma

Summary: this is a dual arm, single centre, investigator initiated study to investigate the use of faza-pet in combination with mri. faza is an investigational radiotracer used in pet scans. faza pet/mri will be used to measure hypoxia in sarcoma tissues and will occur for: arm a: before neo-adjuvant radiation/chemotherapy treatment; arm b: before surgery (optional). after the faza pet/mri scan, patients will be followed up via telephone, 48 hours after the scan, to see if there are any side effects due to faza. up to 30 patients enrolled in arm b will receive pimonidazole approximately 16-20 hours before surgery.

mutliple studies show that hypoxia in sarcoma has been consistently associated with poor treatment outcomes. subsequently, there has been a study that shows inhibition of hypoxia-induced transcription factor (hif-1 alpha), with radiation, was effective in disease treatment in pre-clinical models. this shows how important hypoxia was in playing a role in overall disease outcome and survival. as a means of examining tumor features, such as hypoxia, hybrid pet/mr imaging combines the advantages of mri's soft-tissue and contrast resolution with pet's functional metabolic capabilities. there have been few reports of using 18f-fdg in diagnostic pet/mri. with the use of 18f-faza in this study, parameters such as diffusion, micro-perfusion, and contrast enhancement (as a surrogate marker for viable tumour tissue) can be simultaneously compared with the faza-derived pattern, in a single procedure. the study is being conducted to measure the volume of hypoxic tumor in high-risk sts patients, using faza-pet/mri, before and after neoadjuvant radiotherapy/chemotherapy.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. patients with either: high-risk extremity sts (g2-3, \> 10 cm largest dimension, and leiomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumour, or undifferentiated pleomorphic sarcoma), or: high-risk rps (g2-3, and leiomyosarcoma or dedifferentiated liposarcoma) 3. intention to treat using radiotherapy/chemotherapy/surgery according to the current treatment policies of the sarcoma site group of pm 4. a negative serum pregnancy test within the two-week interval immediately prior to pet-mr imaging, for women of child-bearing age 5. ability to provide written informed consent to participate in the study exclusion criteria: 1. previous radiotherapy to intended treatment volumes. 2. previous systemic therapy 3. active malignancy other than sarcoma 4. unable to remain supine for at least 60 minutes 5. pregnancy or breast feeding 6. age less than 18 years old 7. failure to provide written informed consent 8. contraindication for mr as per current institutional guidelines.

Keywords: hypoxia sarcoma faza pet imaging
development and evaluation of a nursing virtual intervention tailored for pain after cardiac surgery

Conditions: Cardiac Surgery; Pain; Adult; Pain Management

Summary: the purpose of this project is to develop and evaluate the effects of a computer-tailored intervention targeting pain barriers and catastrophizing in adults having cardiac surgery. the hypotheses are that in the experimental group, in comparison to the control group, participants will show lower levels of pain, less pain interference in their activities, less attitudinal barriers, and less pain catastrophizing. a pilot-rct is privileged to assess the preliminary effects of the intervention on the following outcomes: pain intensity, analgesic consumption, pain interference, barriers and pain catastrophizing.


Eligibility criteria:
inclusion criteria: * first intention cardiac surgery * 18 years old or more * able to fill up questionnaires in french exclusion criteria: * participation to another psychosocial intervention * cognitive or psychiatric disorder

Keywords: acute postoperative pain nursing intervention
impact of vitamin d on endothelial function and blood biomarkers including cd28 null cells in ckd

Conditions: CKd Patients With Stage 3 and 4

Summary: vitamin d deficiency is common in ckd and assciated with cv complications. endothelial dysfucntion is common in ckd and is a harbinger of atherosclerosis. the study investigated the impact of vitamin d on endothelial fucntion and blood biomarkers in ckd.


Eligibility criteria:
inclusion criteria: * ckd 3-4 age 18-80 exclusion criteria: * recent mi, cva, malignancy active infection active inflammation high calcium already on viatmin d therapy
care ecosystem: ochsner health system

Conditions: Dementia

Summary: 1. to determine the feasibility and acceptability of the care ecosystem program in the ochsner clinical setting. 2. to assess the effect of the care ecosystem program on health care cost and quality care quality as measured by primary outcome variables. * adapted from the care ecosystem, memory.ucsf.edu/care-ecosystem


Eligibility criteria:
inclusion criteria: * male or female ≥55 years of age at baseline * probable dementia diagnosis as evidenced by one or more of the following criteria: * dementia listed on medical record problem list as of january 1, 2015 or later, or, in the opinion of the referring provider has dementia * prescribed with any of the following: donepezil, memantine, galantamine hbr, rivastigmine, or tartrate; or, in the opinion of the referring provider, could take such medication * lives in community exclusion criteria: * documented history of multiple sclerosis, als, traumatic brain injury, huntington's disease, schizophrenia, bipolar disorder, or current substance abuse disorder * lives in a nursing home or assisted living facility * unable to complete monthly telehealth or phone visits
outcomes after laparotomy for penetrating abdominal trauma

Conditions: Penetrating Abdominal Trauma

Summary: the purpose of this study is to evaluate outcomes of adult patients hospitalised due to penetrating abdominal trauma at a tertiary trauma hospital in south africa. our primary objective is to study the association between waiting time to surgery and outcome (mortality, complications, and length of hospital stay) in normotensive patients treated with laparotomy for penetrating abdominal trauma.


Eligibility criteria:
inclusion criteria: * patients that are admitted due to penetrating abdominal injuries, irrespective of injury mechanism, time from injury and prior treatment. * patients that are treated with laparotomy. exclusion criteria: * patients that are admitted due to blunt trauma or combinations of blunt and penetrating trauma. * patients who are dead on arrival. * patients that are only re-admitted during the study period, i.e. patients that received primary treatment by tbh before study initiation.
the impact on recurrence risk of adjuvant transarterial chemoinfusion (tai) for patients with hepatocellular carcinoma and microvascular invasion (mvi) after hepatectomy : a random, controlled, stage iii clinical trial.

Conditions: Hepatocellular Carcinoma

Summary: to compare the impact on recurrence risk of adjuvant transarterial chemoinfusion (tai) for patients with hepatocellular carcinoma and microvascular invasion (mvi) after hepatectomy.


Eligibility criteria:
inclusion criteria: * older than 18 years old and younger than 75 years; * ecog ps\<3; * proven hepatocellular carcinoma with mvi according pathological examination; * not previous treated for tumor; * tumor was removed in operation; * no recurrence occurence at 4 to 7 weeks after surgery; * the lab test could meet: neutrophil count≥1.5×109/l; hemoglobin≥80g/l; platelet count≥60×109/l; serum albumin≥28g/l; total bilirubin\<3-times upper limit of normal; alt\<5-times upper limit of normal; ast\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; pt≤upper limit of normal plus 6 seconds; inr≤2.3; * sign up consent; * unrolled by other clinical trials about hepatocellular carcinoma. exclusion criteria: * cannot tolerate tai; * cns or bone metastasis exits; * known history of other malignancy; * be allergic to related drugs; * underwent organ transplantation before; * be treated before (interferon included); * known history of hiv infection; * known history of drug or alcohol abuse; * have gi hemorreage or cardiac/brain vascular events within 30 days; * pregnancy;
a long term safety study of degarelix in patients with prostate cancer

Conditions: Prostate Cancer

Summary: patients that completed any of the trials; cs27 (nct00738673), cs28 (nct00831233), cs30 (nct00833248) or cs31 (nct00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. safety parameters such as electrocardiogram (ecg), blood and urine samples and general health state will be studied. note: patients completing the cs27 trial did not participate in the cs34 trial.


Eligibility criteria:
inclusion criteria: * completed any of the trials; fe 200486 cs27, cs28, cs30 or cs31 exclusion criteria: * discontinued any of the trials: fe 200486 cs27, cs28, cs30 or cs31

Keywords: safety parameters ecg, blood and urine samples general health state
helping ovarian cancer patients cope with their illness (hope)

Conditions: Recurrent Ovarian Carcinoma

Summary: this clinical trial compares the effect of the helping ovarian cancer patients cope with their disease (hope) intervention to usual care for the reduction of hopelessness and helplessness in patients with ovarian cancer that has come back after a period of improvement (recurrent). patients with recurrent ovarian cancer are at high risk for increased death and poor mental health outcomes, including depression and anxiety. ovarian cancer is the deadliest of all gynecologic cancers, with a survival rate at five years of only 50%. most patients are diagnosed with advanced disease and have a high chance of recurrent disease that is incurable, even if upfront treatments are effective. ovarian cancer's advanced diagnosis, high likelihood of recurrence and death, and rigorous treatment including surgery and other cancer therapies create high levels of distress and reduced quality of life (qol). patients with recurrent ovarian cancer report high rates of depression and anxiety and poor qol. due to the major distress, reduced qol, and likelihood of death among this population, improving this patient population's qol is a priority. using the hope intervention may be effective in reducing hopelessness and helplessness in recurrent ovarian cancer patients.

outline: aim 1: patients complete the hope intervention workshop virtually or in-person. the workshop consists of 3 sessions, each held once per week and lasting 60 to 90 minutes as well as complete a survey and an interview for hope intervention refinement during follow up. aim 2: patients are randomized to 1 of 2 groups. group i: patients complete the hope intervention workshop virtually or in-person, with 3 sessions held once per week, each lasting 60 to 90 minutes. group ii: patients receive usual care on study. patients in both groups complete baselines and follow up assessments 5, 8, and 12 weeks after the randomization event.

Eligibility criteria:
inclusion criteria: * age 18 years of age or older * english speaking * able to provide informed consent * current diagnosis of recurrent epithelial ovarian cancer (regardless of the amount of time since the diagnosis, given the poor prognosis of this illness with a median survival time of less than 2 years) exclusion criteria: * patients with non-invasive gynecologic disease (i.e., dysplasia)
evaluation of performance of automatic fusion for radiofrequency ablation of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: fusion imaging of us and mri is very helpful for interventional procedure such as radiofrequency ablation in liver. however, manual registration of us and magnetic resonance (mr) imaging is somewhat time-consuming and difficult for less-experienced physicians. recently, automatic registration function was developed to help the fusion of us and ct/mri imaging. the purpose of this trial is to compare the registration time and accuracy of manual registration system and automatic registration system.

1. patients will be randomized and assigned. 2. for automatic registration group, automatic image fusion will be done by rs80a us unit and rf ablation will be performed. image fusion time will be measured. 3. for manual registration group, manual image fusion will be done by logiq-e9 us unit and rf ablation will be performed. image fusion time will be measured. 3) after radiofrequency (rf) ablation, immediate, contrast enhanced ct will be performed to evaluate technical success and complications 4) accuracy of registration will be measured by home-made software using 3d techniques. 5) after one month, technical effectiveness will be evaluated by contrast enhanced ct 6) f/u of ct images will be obtained until one year after rf ablation with a interval of 1-3 months.

Eligibility criteria:
inclusion criteria: * more than 40-years old * patients with hepatic malignancy who will underwent radiofrequency ablation exclusion criteria: * not using fusion imaging (ct guidance or fluoroscopic guidance)

Keywords: radiofrequency ablation image fusion
safety and efficacy study of photopheresis plus standard therapy to treat chronic graft-versus-host disease

Conditions: Graft-versus-Host Disease

Summary: the purpose of this study is to determine whether extracorporeal photoimmune therapy with uvadex (ecp) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (gvhd).

for patients who survive allogeneic bone marrow transplants greater than 100 days, chronic gvhd is a major cause of non-relapse morbidity and mortality. depending on the presence of known associated risk factors, chronic gvhd will occur in 20-50% of these transplant recipients, with mortality rates varying from 20 to 70%. because a lymphocyte-mediated immune reaction is thought to be involved in gvhd, suppression of these cells by means other than medications could have benefit in the gvhd population. ecp is a technique in which peripheral white blood cells are exposed to a photoactivatable compound (uvadex) administered extracorporeally and ultraviolet a light. after cells are reinfused into the patient, their function is altered, thereby activating mechanisms that allow for further regulation of specific lymphocyte populations. the purpose of this study is to determine whether ecp, in conjunction with standard therapy, is effective in the treatment of chronic gvhd. efficacy of the therapy with respect to skin manifestations of the disease will be determined by a blinded skin assessor.

Eligibility criteria:
inclusion criteria: * documented skin disease classical for chronic gvhd (e.g. hypopigmentation, hyperpigmentation, lichenoid lesions, sclerodermatous lesions)greater than or equal to 100 days post transplantation. * patients with documented chronic gvhd that is corticosteroid refractory, corticosteroid dependent or corticosteroid intolerant. * women of childbearing potential must agree to use a reliable method of birth control for the duration of this study. * patients must weight at least 40 kg (88 lbs.) exclusion criteria: * active gastrointestinal bleeding * previous treatment with ecp * females who are pregnant and/or lactating

Keywords: graft-versus-host disease extracorporeal photopheresis
tooth-borne versus tooth-bone-borne rapid maxillary expanders: a stereophotogrammetric evaluation of soft tissues

Conditions: Posterior Crossbite

Summary: the force exerted by the rapid maxillary expansion (rme) appliances provides expansion of the transverse dimension by splitting of the midpalatal suture. this expansion results in three-dimensional (3d) changes in maxillary position which also effects circummaxillary surrounding structures. the aim of this randomized clinical trial (rct) was to evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (rme) on soft tissue with stereophotogrammetry.

introduction: to evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (rme) on soft tissue with stereophotogrammetry. methods: 32 patients (15 males, 17 females) who met inclusion criteria were divided into two groups. in the first group, tooth-borne rme appliance (hyrax) was applied to 16 patients (9 males, 7 females mean age 13.4 ± 1.3 years) and in the second group, tooth-bone-borne rme appliance (hybrid hyrax) was applied to 16 patients (6 males, 10 females mean age 13.05 ±1.24 years). a simple electronically generated randomization was performed before trial commencement using the random allocation software program. allocation concealment involved numbered, sealed, and opaque envelopes prepared before trial commencement. one envelope was sequentially opened for each participant during recruitment. each envelope contained a card with the name of 1 expander. the initials of the name of the participant, the type of expander, and the date of allocation were identified in the external surface of the envelope. one operator was responsible for the randomization process, allocation concealment, and implementation. the primary outcomes of this study was assessment of changes in soft tissues before rme (t0) and post-retention (t1) period by stereophotogrammetry. independent and dependent sample t tests were used to compare intra- and inter-group differences at p\<0.05 significance level.

Eligibility criteria:
inclusion criteria: 1. no previous tonsillar, nasal or adenoid surgery and orthodontic treatment, 2. bilateral crossbite and need for rme, 3. maxillary and mandibular permanent teeth fully erupted, 4. willingness to participate in the study exclusion criteria: 1. the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy 2. having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene, 3. history of previous orthodontic treatment.

Keywords: stereophotogrammetry tooth-bone-borne rapid maxillary expansion skeletal anchorage mini-screws
platelet indices could predict spontaneous bacterial peritonitis in cirrhotic ascitic patients

Conditions: Cirrhosis, Liver

Summary: spontaneous bacterial peritonitis (sbp) is an ascitic fluid infection in cirrhotic patients

platelet indices can be utilized as a non-invasive predictor of sbp.

Eligibility criteria:
inclusion criteria: * cirrhotic patients and ascites exclusion criteria: * patients with ascites due to causes other than cirrhosis- immunocompromised patients, * patients with abnormal thrombocytes due to non-hepatic causes.
lifestyleintervention for the treatment of severe obesity

Conditions: Morbid Obesity

Summary: the overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (\> 1 year) term effects on body composition and psychological health after a 10 to 14-weeks comprehensive lifestyle modification program for the treatment of severe obesity. the aims of the phd project are to investigate whether an intensive lifestyle intervention leads to acute and short term (\< 1 year) changes in: 1. the bmi/weight 2. body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and visceral fat area) 3. psychosocial factors such as eating behavior, anxiety and depression symptoms and health-related quality of life

the study is based on data collected from patients at the hjelp24 nimi ringerike obesity clinic, which is an inpatient program to address morbid obesity in adults. the study is a non-randomized clinical trial comparing the acute and long-term effects on physical and psychological health of the 10-14-weeks inpatient comprehensive lifestyle modification program for the treatment of morbidly obese patients. in between the inpatient stay, the patients are followed up either by telephone, occasional mail and/or structured / weekly email. in this project we prospectively follow two groups of patient included in the treatment programme in september 2010 and january 2011, respectively. in addition a control group with waiting-list patients is also included in the study, and they were recruited in october-november 2011

Eligibility criteria:
inclusion criteria: * morbidly obese exclusion criteria: * not able to walk slowly for 20 minutes

Keywords: lifestyle physical activity
real-world evidence prospective study on the effect of nab-paclitaxel treatment on the clinical outcomes and hrqol in patients with mbc in greece

Conditions: Metastatic Breast Cancer

Summary: this non-interventional study aims at assessing the impact of nab-paclitaxel on the clinical outcomes and the health-related qol (hrqol) of this heavily burdened and difficult-to-treat population. notably, the data generated in the context of this study will serve as complementary evidence to that of the tightly and strictly controlled pre-registration clinical trial setting, which is of essential importance especially in patient populations with diseases of complex and heterogeneous biology, such as breast cancer.


Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this study have to meet all of the following criteria: * adult patients (18 years and older); * patients with a histologically or cytologically confirmed diagnosis of mbc who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated; * patients for whom the decision to prescribe therapy with nab-paclitaxel according to the locally approved product's summary of product characteristics (smpc) has already been taken prior to their enrolment in the study; the assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of nab-paclitaxel is clearly separated from the physician's decision to include the patient in the current study; * patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol; * patients must have signed an informed consent document; * patients must be able to read, understand and complete the study specific questionnaire exclusion criteria: a patient who meets any of the following criteria will be excluded from participation in this study: * patients who have initiated treatment with nab-paclitaxel more than 7 days prior to their enrolment into the study; * patients that meet any of the contraindications to the administration of the study drug according to the approved smpc; * receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nab-paclitaxel.